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The Food and Drug Administration has issued guidance on how medical device firms let the public know about side effects that are discovered once those products are on the market.

The FDA issued its final guidelines for “emerging signals,” (PDF) or new information about a marketed medical device. “New information about a devices safety and/or effectiveness, including unanticipated adverse events, may become available once the device is more widely distributed and used under real-world conditions and in broader patient populations than may have been studied in support of a marketing application. Also, subsequent changes made to the device, its manufacturing process, or supply chain may lead to new safety problems,” according to the FDA guidance document.

The new guidance lays out a process for new information related to devices on the market, including collection of available material, interaction with the medical device company, review by subject matter experts, stakeholder management and management oversight.

The agency said it issued this guidance to give health care providers, patients and consumers access to the most current information about a device that may help inform their patient management decision making. 

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